ADVIA Centaur Calcitonin (CALCT) assay
K-Number: K182012 · 2018-12-21
ApplicantAxis-Shield Diagnostics Limited
Decision Date2018-12-21
Product CodeJKR
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
ADVIA Centaur Calcitonin (CALCT) assay is a medical device manufactured by Axis-Shield Diagnostics Limited. It received FDA 510(k) clearance on 2018-12-21 under approval number K182012. The device is classified under product code JKR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ADVIA Centaur Calcitonin (CALCT) assay?
ADVIA Centaur Calcitonin (CALCT) assay is a medical device that received FDA 510(k) clearance on 2018-12-21. It is manufactured by Axis-Shield Diagnostics Limited. The 510(k) number is K182012.
When was ADVIA Centaur Calcitonin (CALCT) assay approved by the FDA?
ADVIA Centaur Calcitonin (CALCT) assay received FDA 510(k) clearance on 2018-12-21, under approval number K182012.
What company makes ADVIA Centaur Calcitonin (CALCT) assay?
ADVIA Centaur Calcitonin (CALCT) assay is manufactured by Axis-Shield Diagnostics Limited.
What is the FDA product code for ADVIA Centaur Calcitonin (CALCT) assay?
The FDA product code for ADVIA Centaur Calcitonin (CALCT) assay is JKR.
Other Devices by Axis-Shield Diagnostics Limited
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K160757ADVIA Centaur Active-B12 (Holotranscobalamin)(AB12) Assay, ADVIA Centaur Active-B12(AB12) Quality Control, and ADVIA Centaur Active-B12 (AB12) Master Curve Materials (MCM)
K183088ADVIA Centaur Erythropoietin (EPO) assay
Related Devices (Code: JKR)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.